Inguinal Lymph Nodes EnlargedNCT07331129
The Analgesic Efficacy of Ultrasound Guided Transversalis Fascia Plane Block in Inguinal Lymph Node Dissection
A study testing transversalis fascia plane block and surgical sit local anesthetic infiltration in people with Inguinal Lymph Nodes Enlarged, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
Pain accompanying Inguinal lymph node dissection triggers a complex stress response leading to impairment of pulmonary, immunological and metabolic function. Opioids are the current gold standard drug for postoperative pain relief, however exposure to large doses lead to multiple side effects of varying significance… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Inguinal Lymph Nodes Enlarged
- What is being tested?
- transversalis fascia plane block and surgical sit local anesthetic infiltration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Dec 2025to 29 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- American society of anesthesiologists (ASA) class I and II.
- Age ≥ 18 and ≤ 65 Years.
- Cancer patients for inguinal lymph node dissection.
- Body mass index (BMI): > 20 kg/m2 and < 40 kg/m2.
Who cannot join
- Patient refusal.
- Local infection at the puncture site.
- Coagulopathies with platelets count below 50,000 or an INR>1.6.
- Unstable cardiovascular disease.
- History of psychiatric and cognitive disorders.
- Patients allergic to medication used.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
National Cancer Institute Cairo University
Cairo, 11796
About this study
Official title: Evaluation of Peri-operative Analgesic Efficacy of Ultrasound Guided Transversalis Fascia Plane Block in Cancer Patients Undergoing Inguinal Lymph Node Dissection: A Prospective Randomized Controlled Study
Pain accompanying Inguinal lymph node dissection triggers a complex stress response leading to impairment of pulmonary, immunological and metabolic function. Opioids are the current gold standard drug for postoperative pain relief, however exposure to large doses lead to multiple side effects of varying significance such as nausea, vomiting, dizziness, constipation, respiratory depression, hypoventilation and sleep disordered breathing. Therefore, strategies other than opioids are recommended without sacrificing proper and effective analgesia, especially in cancer patients who are more susceptible to tolerance and addiction.
Transversalis Fascia Plane Block is used in patients undergoing various surgeries like iliac crest bone harvesting, appendicectomy, cecostomy and inguinal hernia repair, often in combination with TAP block. The initial description of TFPB was with patients in the supine position, with a linear array or curvilinear probe placed between the iliac crest and the costal margin. The external oblique, internal oblique and transversus abdominis muscles and the transversus aponeurosis are identified. The entry of the needle has to be in-plane, from the anterior aspect, and after traversing through the deep surface of the transversus abdominis muscle, local anesthetic is injected to separate the transversalis fascia from the transversus muscle. Studies have demonstrated that this intervention blocks the proximal branches of T12 and L1 and to a lesser extent T11 in the plane between the transversus abdominis muscle and the transversalis fascia. Since its initial description, ultrasound (US)-guided TFPB has been explored in many randomized controlled trials for patients undergoing iliac crest bone harvesting, lower segment caesarean section (LSCS), inguinal hernia repair and hip surgeries.
Read the detailed description
Inguinal lymph node dissection (ILND) is the surgical removal of lymph nodes from the groin. Inguinal lymph node dissection is used to diagnose cancer spread from certain areas (usually penis, vulva, anus or the skin of the legs or torso), remove lymph nodes that may be cancerous or have a high chance of becoming cancerous, reduce the risk that cancer will recure in the future and help providers to determine the options for treatment. ( Pain accompanying ILND triggers a complex biochemical and physiological stress response leading to impairment of pulmonary, immunological and metabolic function. Opioids are the current gold standard drug for postoperative pain relief, however exposure to large doses lead to multiple side effects of varying significance such as nausea, vomiting, dizziness, constipation, respiratory depression, hypoventilation and sleep disordered breathing . Therefore, strategies other than opioids are recommended without sacrificing proper and effective analgesia, especially in cancer patients who are more susceptible to tolerance and addiction.
Ultrasound imaging made the practice of regional anesthesia easier in visualization and identification of usual and unusual position of nerves, blood vessels, needle during its passage through the tissues, as well as deposition and spread of local anesthetics in the desired plane and around the desired nerve . Several abdominal wall blocks are being used by anesthesiologists to provide postoperative analgesia for surgeries involving lower abdominal incisions. Transversus abdominis plane (TAP) block, quadratus lumborum block (QLB) and ilioinguinal-iliohypogastric block (IIIB). Transversalis fascia plane block (TFPB) was first described by Hebbard in the year 2009.
TFPB is used in patients undergoing various surgeries like iliac crest bone harvesting, appendicectomy, cecostomy and inguinal hernia repair, often in combination with TAP block. The initial description of TFPB was with patients in the supine position, with a linear array or curvilinear probe placed between the iliac crest and the costal margin. The external oblique, internal oblique and transversus abdominis muscles and the transversus aponeurosis are identified. The entry of the needle has to be in-plane, from the anterior aspect, and after traversing through the deep surface of the transversus abdominis muscle, local anesthetic is injected to separate the transversalis fascia from the transversus muscle. Studies have demonstrated that this intervention blocks the proximal branches of T12 and L1 and to a lesser extent T11 in the plane between the transversus abdominis muscle and the transversalis fascia. Since its initial description, ultrasound (US)-guided TFPB has been explored in many randomized controlled trials for patients undergoing iliac crest bone harvesting, lower segment caesarean section (LSCS), inguinal hernia repair and hip surgeries.
To our knowledge, there is no randomized controlled study about it until now in cancer patients undergoing inguinal lymph node dissection, so it will be one of the earliest studies that evaluate peri-operative analgesia efficacy of ultrasound guided transversalis fascia plane block in cancer patients undergoing inguinal lymph node dissection.
- Conditions
- Inguinal Lymph Nodes Enlarged
- Being tested
- transversalis fascia plane block and surgical sit local anesthetic infiltration
- Keywords
- transversalis fascia plane block, ultrasound, inguinal lymph node dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transversalis fascia plane block and surgical sit local anesthetic infiltrationProcedure or surgery
inguinal fascial plane block and surgical site local anesthetic infiltration
| Study group | Role | What they receive |
|---|---|---|
| ultrasound guided transversalis fascia plane block (TFPB). | Active comparator | Under aseptic precaution, TFPB will be performed under ultrasonographic guidance using a low-frequency convex transducer (Sonosite M turbo, USA). The patient will be placed in the lateral position. The probe will be introduced to orientation just above the iliac crest transversely; and the three abdominal muscle layers will be identified. Then the probe will be moved posteriorly to show the point at which the transversus abdominis muscle and the internal oblique muscle connected into a common fascia, which is just near the quadratus lumborum muscle. A 22-gauge 80-mm block needle will be used just to pierce the transversalis fascia. To confirm the correct needle tip placement, hydro-dissection will be performed using 2 mL of 0.9% saline following a negative check for blood aspiration to be safe from vascular puncture, then 20 ml of 0.25% bupivacaine will be injected. The real-time US scanning confirmed the spread of the LA in the target plane Receives: Procedure: transversalis fascia plane block and surgical sit local anesthetic infiltration |
| surgical incision site infiltration with the local anesthetics. | Active comparator | Patients of this group will receive local anesthetic 20 ml of 0.25% bupivacaine infiltration into the cutaneous and subcutaneous tissues at the surgical site. Receives: Procedure: transversalis fascia plane block and surgical sit local anesthetic infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores using Visual analogue score
Pain scores using Visual analogue score (VAS) (0 mm = no pain to 10mm = worst pain imaginable) at predetermined time intervals (0,1, 2, 4,6, 12 and 24h) postoperative.
Measured: 24 hours after the surgery
Secondary outcomes (5)
Total intra-operative fentanyl consumption
the rescue analgesia will be administered intra-operative by fentanyl IV and the total fentanyl used will be recorded and compared between the groups
Measured: 2-3 hours (Surgery time) surgery
1st time opioids requested post-operative.
In case of postoperative pain recorded, rescue analgesia will be provided as IV morphine (3 mg) then continuous infusion of morphine through Patient Controlled Analgesia ( PCA ) to keep the VAS scores<3. The total 24-hour morphine consumption will be recorded for every patient.
Measured: 24 hours after the surgery
Total post-operative morphine consumption.
The total 24-hour morphine consumption will be recorded for every patient post operative.
Measured: 24 hours after the surgery
Changes and stability in Mean Arterial Blood Pressure (MAP)
Change in Mean Arterial Blood Pressure (MAP) in mmHg
Measured: every 15 minutes during the surgery then at 1, 2, 4, 8, 12, 16, 20 and 24 hours postoperatively
Changes and stability in Heart Rate (HR)
Change in heart rate (HR) in beat\min
Measured: every 15 minutes during the surgery then at 1, 2, 4, 8, 12, 16, 20 and 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start22 Dec 2025
- Primary completion28 Jun 2026 (estimated)
- Study completion29 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal Lymph Nodes EnlargedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Sharawy Abdel Rahman Aboul Nasr, National Cancer Institute, Egypt
- Investigators
- Ayman Sharawy Abdel Rahman Aboul Nasr, MD, Principal investigator, National Cancer Institute Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07331129
- Sponsor's protocol ID
- AP2510-501-130-203
- Status last verified
- Dec 2025
- First submitted
- 28 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Peri-operative Analgesic Efficacy of Ultrasound Guided Transversalis Fascia Plane Block in Cancer Patients Undergoing Inguinal Lymph Node Dissection: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07331129
- Acronym / sponsor ID
- AP2510-501-130-203
- Conditions
- Inguinal Lymph Nodes Enlarged
- Keywords
- transversalis fascia plane block, ultrasound, inguinal lymph node dissection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- 28 Jun 2026 (estimated)
- Study completion
- 29 Jun 2026 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pain accompanying Inguinal lymph node dissection triggers a complex stress response leading to impairment of pulmonary, immunological and metabolic function. Opioids are the current gold standard drug for postoperative pain relief, however exposure to large doses lead to multiple side effects of varying significance such as nausea, vomiting, dizziness, constipation, respiratory depression, hypoventilation and sleep disordered breathing. Therefore, strategies other than opioids are recommended without sacrificing proper and effective analgesia, especially in cancer patients who are more susceptible to tolerance and addiction.
Transversalis Fascia Plane Block is used in patients undergoing various surgeries like iliac crest bone harvesting, appendicectomy, cecostomy and inguinal hernia repair, often in combination with TAP block. The initial description of TFPB was with patients in the supine position, with a linear array or curvilinear probe placed between the iliac crest and the costal margin. The external oblique, internal oblique and transversus abdominis muscles and the transversus aponeurosis are identified. The entry of the needle has to be in-plane, from the anterior aspect, and after traversing through the deep surface of the transversus abdominis muscle, local anesthetic is injected to separate the transversalis fascia from the transversus muscle. Studies have demonstrated that this intervention blocks the proximal branches of T12 and L1 and to a lesser extent T11 in the plane between the transversus abdominis muscle and the transversalis fascia. Since its initial description, ultrasound (US)-guided TFPB has been explored in many randomized controlled trials for patients undergoing iliac crest bone harvesting, lower segment caesarean section (LSCS), inguinal hernia repair and hip surgeries.
Detailed description
Inguinal lymph node dissection (ILND) is the surgical removal of lymph nodes from the groin. Inguinal lymph node dissection is used to diagnose cancer spread from certain areas (usually penis, vulva, anus or the skin of the legs or torso), remove lymph nodes that may be cancerous or have a high chance of becoming cancerous, reduce the risk that cancer will recure in the future and help providers to determine the options for treatment. ( Pain accompanying ILND triggers a complex biochemical and physiological stress response leading to impairment of pulmonary, immunological and metabolic function. Opioids are the current gold standard drug for postoperative pain relief, however exposure to large doses lead to multiple side effects of varying significance such as nausea, vomiting, dizziness, constipation, respiratory depression, hypoventilation and sleep disordered breathing . Therefore, strategies other than opioids are recommended without sacrificing proper and effective analgesia, especially in cancer patients who are more susceptible to tolerance and addiction.
Ultrasound imaging made the practice of regional anesthesia easier in visualization and identification of usual and unusual position of nerves, blood vessels, needle during its passage through the tissues, as well as deposition and spread of local anesthetics in the desired plane and around the desired nerve . Several abdominal wall blocks are being used by anesthesiologists to provide postoperative analgesia for surgeries involving lower abdominal incisions. Transversus abdominis plane (TAP) block, quadratus lumborum block (QLB) and ilioinguinal-iliohypogastric block (IIIB). Transversalis fascia plane block (TFPB) was first described by Hebbard in the year 2009.
TFPB is used in patients undergoing various surgeries like iliac crest bone harvesting, appendicectomy, cecostomy and inguinal hernia repair, often in combination with TAP block. The initial description of TFPB was with patients in the supine position, with a linear array or curvilinear probe placed between the iliac crest and the costal margin. The external oblique, internal oblique and transversus abdominis muscles and the transversus aponeurosis are identified. The entry of the needle has to be in-plane, from the anterior aspect, and after traversing through the deep surface of the transversus abdominis muscle, local anesthetic is injected to separate the transversalis fascia from the transversus muscle. Studies have demonstrated that this intervention blocks the proximal branches of T12 and L1 and to a lesser extent T11 in the plane between the transversus abdominis muscle and the transversalis fascia. Since its initial description, ultrasound (US)-guided TFPB has been explored in many randomized controlled trials for patients undergoing iliac crest bone harvesting, lower segment caesarean section (LSCS), inguinal hernia repair and hip surgeries.
To our knowledge, there is no randomized controlled study about it until now in cancer patients undergoing inguinal lymph node dissection, so it will be one of the earliest studies that evaluate peri-operative analgesia efficacy of ultrasound guided transversalis fascia plane block in cancer patients undergoing inguinal lymph node dissection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrasound guided transversalis fascia plane block (TFPB). | Active comparator | Procedure: transversalis fascia plane block and surgical sit local anesthetic infiltrationUnder aseptic precaution, TFPB will be performed under ultrasonographic guidance using a low-frequency convex transducer (Sonosite M turbo, USA). The patient will be placed in the lateral position. The probe will be introduced to orientation just above the iliac crest transversely; and the three abdominal muscle layers will be identified. Then the probe will be moved posteriorly to show the point at which the transversus abdominis muscle and the internal oblique muscle connected into a common fascia, which is just near the quadratus lumborum muscle. A 22-gauge 80-mm block needle will be used just to pierce the transversalis fascia. To confirm the correct needle tip placement, hydro-dissection will be performed using 2 mL of 0.9% saline following a negative check for blood aspiration to be safe from vascular puncture, then 20 ml of 0.25% bupivacaine will be injected. The real-time US scanning confirmed the spread of the LA in the target plane |
| surgical incision site infiltration with the local anesthetics. | Active comparator | Procedure: transversalis fascia plane block and surgical sit local anesthetic infiltrationPatients of this group will receive local anesthetic 20 ml of 0.25% bupivacaine infiltration into the cutaneous and subcutaneous tissues at the surgical site. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American society of anesthesiologists (ASA) class I and II.
- Age ≥ 18 and ≤ 65 Years.
- Cancer patients for inguinal lymph node dissection.
- Body mass index (BMI): > 20 kg/m2 and < 40 kg/m2.
Key exclusion criteria (6 listed)
- Patient refusal.
- Local infection at the puncture site.
- Coagulopathies with platelets count below 50,000 or an INR>1.6.
- Unstable cardiovascular disease.
- History of psychiatric and cognitive disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transversalis fascia plane block and surgical sit local anesthetic infiltrationinguinal fascial plane block and surgical site local anesthetic infiltration | Procedure or surgery | surgical incision site infiltration with the local anesthetics., ultrasound guided transversalis fascia plane block (TFPB). |
Primary outcome
Pain scores using Visual analogue score
Time frame: 24 hours after the surgery
Pain scores using Visual analogue score (VAS) (0 mm = no pain to 10mm = worst pain imaginable) at predetermined time intervals (0,1, 2, 4,6, 12 and 24h) postoperative.
5 secondary outcomes
Total intra-operative fentanyl consumption
Time frame: 2-3 hours (Surgery time) surgery
1st time opioids requested post-operative.
Time frame: 24 hours after the surgery
Total post-operative morphine consumption.
Time frame: 24 hours after the surgery
Changes and stability in Mean Arterial Blood Pressure (MAP)
Time frame: every 15 minutes during the surgery then at 1, 2, 4, 8, 12, 16, 20 and 24 hours postoperatively
Changes and stability in Heart Rate (HR)
Time frame: every 15 minutes during the surgery then at 1, 2, 4, 8, 12, 16, 20 and 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ayman Sharawy Abdel Rahman Aboul Nasr, MD principal investigator
National Cancer Institute Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transversalis fascia plane block and surgical sit local anesthetic infiltration in people with Inguinal Lymph Nodes Enlarged, run by National Cancer Institute, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayman Sharawy Abdel Rahman Aboul Nasr, MD (01282649008 ext. 0020, ayman.sharawy@nci.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores using Visual analogue score (time frame: 24 hours after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.